Thank you for your interest in our services!

To apply for MDR certification, you can download and fill in the Preliminary Data Collection Form for Medical Device Certification – MDR 2017/745 and see the document Description and submission of the medical device certification application – MDR 2017/745.

For communication of changes to legacy devices, you can download and fill in the form Communication of changes to legacy devices.

Alternatively, you can contact us at info@entecerma.it or through our website. One of our Sales Managers will be in touch with you as soon as possible to explain the ECM offer for the medical device sector.